ENDOSCOPIC TREATMENT FOR ULCER BLEEDING (USING CORI)

溃疡出血的内镜治疗（使用 CORI）

• 批准号: 2823226
• 负责人: DAVID E FLEISCHER
• 金额: $ 7.64万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2823226
• 关键词: clinical research; clinical trials; data collection; duodenal ulcer; endoscopy; epinephrine; gastrointestinal disorder chemotherapy; gastrointestinal hemorrhage; human subject; human therapy evaluation; outcomes research; peptic ulcer

The effectiveness of endoscopic therapy for ulcers with non-bleeding visible vessels (NBVV) has not been studied in multiple practice settings throughout the United States. The American Society for Gastrointestinal Endoscopy (ASGE) - Clinical Outcomes Research Initiative (CORI) Project - is a national consortium of gastrointestinal specialists that collects endoscopic data utilizing a computerized endoscopic database to study outcomes in endoscopy. THE PRIMARY AIM OF THIS PILOT/FEASIBILITY STUDY IS TO DEMONSTRATE THE ABILITY OF A NATIONAL CONSORTIUM OF CLINICAL PRACTITIONERS TO COLLECT EFFECTIVENESS DATA COMPARING TWO ENDOSCOPIC TREATMENTS FOR ULCERS WITH NBVV. The efficacy and safety of bipolar coagulation (BP) alone will be compared to bipolar coagulation after injection with epinephrine (BP/E). By incorporating and testing trial data collection this will permit the expansion of data collection in a multicenter study involving practicing physicians in multiple geographic sites in a variety o practice settings. A unique aspect of this study is that it is the first effectiveness and safety study of upper gastrointestinal bleeding (UGIB) performed in multiple practice sites across the United States. Data will be entered at 16 sites and transmitted electronically for analysis. By testing the expanded database structure by implementing this pilot study, the groundwork will be lain for a larger study in which clinical, safety, and economic outcomes will be investigated making use of the CORI data collection infrastructure.

美国各地尚未对内窥镜治疗可见血管不出血溃疡 (NBVV) 的有效性进行研究。 美国胃肠内窥镜协会 (ASGE) - 临床结果研究计划 (CORI) 项目 - 是一个由胃肠道专家组成的全国性联盟，利用计算机内窥镜数据库收集内窥镜数据来研究内窥镜检查的结果。 本试点/可行性研究的主要目的是展示全国临床医生联盟收集比较两种内镜治疗溃疡与 NBVV 的有效性数据的能力。 将单独双极凝固（BP）与注射肾上腺素后双极凝固（BP/E）的疗效和安全性进行比较。 通过合并和测试试验数据收集，这将允许扩大多中心研究中的数据收集，该研究涉及多个地理位置的执业医师在各种实践环境中的情况。 这项研究的独特之处在于，它是第一个在美国多个诊所进行的上消化道出血 (UGIB) 有效性和安全性研究。 数据将在 16 个地点输入并以电子方式传输以供分析。 通过实施这项试点研究来测试扩展的数据库结构，将为更大规模的研究奠定基础，其中将利用 CORI 数据收集基础设施来调查临床、安全性和经济结果。